Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases
Supportive Care in Cancer, Volume 20, No. 12, Year 2012
Notification
URL copied to clipboard!
Description
Purpose Quality of life (QOL) is frequently an endpoint in clinical trials involving patients with advanced cancer. Statistical significance of minimal differences can be achieved with sufficient sample size, yet the actual clinical relevance is unknown. The purpose of this study was to establish the minimal clinically important difference (MCID) for the European Organisation for Research and Treatment of Cancer (EORTC) bone metastases module (EORTC QLQ-BM22). Methods Patients with bone metastases across seven countries were prospectively enrolled in a trial validating the EORTC QLQ-BM22 and completed the QLQ-BM22 and core measure (QLQ-C30) at baseline and 1-month follow-up. MCIDs were calculated for each QOL scale for both improvement and deterioration using both an anchor- (performance status) and distribution-based approach. Results A total of 93 patients completed both baseline and follow-up QOL and had recorded performance status at both intervals. Statistically significant meaningful differences were seen in seven scales. Improvements of 30.5 (95 % confidence interval, 9.0 to 52.0), 20.1 (7.1 to 33.2), 30.5 (13.8 to 47.3) and 19.6 (5.0 to 34.3) in the pain, painful site, painful characteristic and functional interference scales, respectively, demonstrated clinical relevance. Decreases of 12.4 (0.3 to 24.6), 22.4 (11.8 to 32.9) and 13.5 (1.9 to 25.1) were required to represent clinically relevant deterioration in emotional functioning, global health status and financial issues, respectively. Minimal differences for improvement were closest to 0.5 standard deviations (SD) while for deterioration, closer to 0.3 SD on the QLQ-BM22. Conclusion Identification of requirements for clinical significance can assist in determining the relevance ofQOL changes after treatment and in sample size determination in future clinical trials. Our study is limited by the small sample size. Future studies should continue to determine MCIDs and confirm our findings using a variety of appropriate anchors and in a larger sample. © Springer-Verlag 2012.
Authors & Co-Authors
Zeng, Liang
Canada, Toronto
University of Toronto
Chow, Edwardedward L.W.
Canada, Toronto
University of Toronto
Zhang, Liying
Canada, Toronto
University of Toronto
Tseng, Lingming
Taiwan, Taipei
National Yang-ming University Taiwan
Hou, Mingfeng
Taiwan, Kaohsiung
Kaohsiung Medical University Chung-ho Memorial Hospital
Fairchild, Alysa M.
Canada, Edmonton
Cross Cancer Institute
Vassiliou, Vassilios P.
Cyprus, Nicosia
Bank of Cyprus Group Oncology Centre
Jesus-Garcia, Reynaldo
Brazil, Sao Paulo
Universidade Federal de São Paulo
el-Din, Mohamed Alm
Egypt, Tanta
Tanta University Hospitals
Kumar, Aswin
India, Thiruvananthapuram
Regional Cancer Centre India
Forges, Fabien
France, Saint-etienne
Université Jean Monnet Saint Etienne
Chie, Wei-Chu
Taiwan, Taipei
National Taiwan University
Bedard, Gillian
Canada, Toronto
University of Toronto
Bottomley, Andrew
Belgium, Brussels
European Organisation for Research and Treatment of Cancer
Statistics
Citations: 22
Authors: 14
Affiliations: 11
Identifiers
Doi:
10.1007/s00520-012-1484-x
ISSN:
09414355
e-ISSN:
14337339
Research Areas
Cancer
Disability
Study Design
Cohort Study